Table 2 Comparison of various outcomes between the two arms.

From: Impact of nicotine replacement therapy as an adjunct to anti-tuberculosis treatment and behaviour change counselling in newly diagnosed pulmonary tuberculosis patients: an open-label, randomised controlled trial

Outcomes

Counselling+ NRT

Counselling alone

Difference (95% C.I.)

p value

mITT analysis

Primary outcome :

TB score

n

Baseline

Eight week

Change

24 weeks

Change

398

7·87 ± 1·2

3·10 ± 1·9

4·76 ± 2·05

2·38 ± 1·6

5·48 ± 1·8

397

7·82 ± 1·3

3·36 ± 1·9

4·46 ± 2·12

2·37 ± 1·5

5·45 ± 1·8

−0·04 (−0·22, 0·13)

0·25 (−0·02, 0·52)

0·29 (0·007, 0·59)

0·006 (0·22, −0·21)

0·039 (0·29, −0·21)

0·61

0·07

0·045

0·95

0.72

Sputum culture conversion

n

Baseline

8-weeks

398

02(0·5%)

379(95·2%)

397

02(0·5%)

379(95·5%)

—

—

1·00

1·00

Per Protocol analysis

TBscore

n

Baseline

8-weeks

Change

24-weeks

Change

379

7·84 ± 1·19

2·84 ± 1·60

5·00 ± 1·79

2·07 ± 0·94

5·76 ± 1·34

379

7·83 ± 1·32

3·15 ± 1·72

4·67 ± 1·92

2·12 ± 0·96

5·70 ± 1·43

0·01(0·16, −0·19)

0·31(0·07, 0·54)

0·32(0·058, 0·59)

0·04(−0·09, 0·17)

0·05(−0·14, 0·25)

0·88

0·010

0·016

0·54

0·58

Sputum culture conversion

n

Baseline

8-weeks

379

02

379 (100%)

379

02

379(100%)

—

—

1·000

1·000

Secondary Outcome

Sputum smear Conversion

n

Baseline

8-weeks

378

00

378

378

00

379

—

—

1·000

Weight (kg)(Mean ± SD)

Baseline

24-weeks Change

49·45 ± 6·9

53·47 ± 6·9

3·1 ± 2·3

50·22 ± 7·3

52·58 ± 6·5

3·1 ± 1·9

−0·78(−1·8, 0·2)

0·04(−0·2, 0·3)

−0·88(−1·8,0·07)

0·120

0·070

0·760

Self-reported quit rate*

n

Eight week

24-weeks

379

222(58·5%)

263(69·3%)

379

91(24·01%)

147(38·7%)

0·4(0·29, 0·42)

0·3(0·23, 0·36)

<0·001

<0·001

Biochemical quit rate

Eight week

24-weeks

73(19·3%)

180(47·8%)

47(12·5%)

121(32·4%)

0·07(0·02, 0·12)

0·15(0·08, 0·21)

<0·001

<0·001

  1. One patient from the counselling + NRT arm and three from the counselling arm were excluded from the analysis as they were diagnosed with multidrug-resistant tuberculosis infection, one patient in the counselling + NRT arm died in a road traffic accident before the first follow-up and was excluded from the analysis. Abbreviations: mITT = modified intention to treat, ATT = Anti-tuberculosis therapy NRT = nicotine replacement therapy, C.I. = confidencce interval. Data are presented as mean ± SD· Values of significance assessed using Student’s t-test, TBscore = validated, composite marker of tuberculosis related clinical outcome, *Self reported, Biochemical quit rates = patients with serum cotinine <10 ng/mL and/or Breath analysis test <6 parts per million.
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